CarboClear Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Carbofix Orthopedics Ltd

Identity

Trade Name: CarboClear Pedicle Screw System FDA UDI
Generic Name: Surgical instrument torque limiter FDA UDI
Device Name: Torque Limiter 3.5 Nm for use with the CarboClear Pedicle Screw System. FDA UDI
Model / Reference: Torque Limiter 3.5 Nm FDA UDI
Description: Torque Limiter 3.5 Nm for use with the CarboClear Pedicle Screw System. FDA UDI

Identifiers

Catalog Number: PPS925140 FDA UDI
Primary DI / UDI-DI: 07290110206376 FDA UDI
510(k) Number: K173487 FDA UDI
K182377 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Surgical instrument torque limiter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument torque limiter

CarboClear Pedicle Screw System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Carbofix Orthopedics Ltd

Sources (1)

FDA UDI 7708674a-c127-4794-b3f4-0936a73343d4 36 fields · synced May 30, 2026